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OBJECTIVES: UK standardised packaging legislation was introduced alongside pack size and product descriptor restrictions of the European Union Tobacco Products Directive to end tobacco marketing and misinformation via the pack. This paper aims to assess compliance with the restrictions and identify attempts to continue to market tobacco products and perpetuate misperceptions of harm post legislation. DESIGN, SETTING AND INTERVENTION: A prospective study of the introduction of standardised packaging of tobacco products to the UK. PARTICIPANTS AND OUTCOMES: We analysed commercial sales data to assess whether the legally required changes in pack branding, size and name were implemented. To explore any adaptations to products and packaging we analysed sales data, monthly pack purchases of factory-made (FM) cigarettes and roll-your-own (RYO) tobacco, tobacco advertisements from retail trade magazines and articles on tobacco from commercial literature (retail trade, market analyst and tobacco company publications). RESULTS: One month after full implementation of the UK and European Union policies, 97% FM and 98% RYO was sold in compliant packaging. Nevertheless, tobacco companies made adaptations to tobacco products which enabled continued brand differentiation after the legislation came into force. For example, flavour names previously associated with low tar were systematically changed to colour names arguably facilitating continued misperceptions about the relative harms of products. Tobacco companies used the 1-year sell-through to their advantage by communicating brand name changes and providing financial incentives for retailers to buy large volumes of branded packs. In addition, tobacco companies continued to market their products to retailers and customers by innovating exemptions to the legislation, namely, filters, packaging edges, seals, multipack outers, RYO accessories, cigars and pipe tobacco. CONCLUSIONS: Tobacco companies adapted to packaging restrictions by innovating their tobacco products and ...

BACKGROUND: Tobacco companies use a host of strategies to undermine public health efforts directed to reduce and eliminate smoking. The success, failure and trends in domestic litigation used by tobacco companies to undermine tobacco control are not well understood, with commentators often assuming disputes are trade related or international in nature. We analyse domestic legal disputes involving tobacco companies and public health actors in high-income countries across the last decade to ascertain the types of action and the success or failure of cases, develop effective responses. METHODS: WorldLii, a publicly available online law repository, was used to identify domestic court cases involving tobacco companies from 2004 to 2014, while outcome data from LexisNexis and Westlaw databases were used to identify appeals and trace case history. RESULTS: We identified six domestic cases in the UK, Australia and Canada, noting that the tobacco industry won only one of six cases; a win later usurped by legislative reform and a further court case. Nevertheless, we found cases involve significant resource costs for governments, often progressing across multiple jurisdictional levels. DISCUSSION: We suggest that, in light of our results, while litigation takes up significant time and incurs legal costs for health ministries, policymakers must robustly fend off suggestions that litigation wastes taxpayers' money, pointing to the good prospects of winning such legal battles.

International audience ; Objective: To examine the impact of the ban on smoking in enclosed public places implemented in England in July 2007 on children's exposure to secondhand tobacco smoke. Design: Repeated cross-sectional surveys of the general population in England. Setting: The Health Survey for England Participants: Confirmed non-smoking children aged 4-15 with measured saliva cotinine participating in surveys from 1998 to 2008, a total of 10,825 children across years. Main outcome measures: The proportion of children living in homes reported to be smoke free; the proportion of children with undetectable concentrations of cotinine; geometric mean cotinine as an objective indicator of overall exposure. Results: Significantly more children with smoking parents lived in smoke-free homes in 2008 (48.1%, 95%CI 43.0-53.1) than in either 2006 (35.5%, 95% CI 29.7-41.7) or the first 6 months of 2007, immediately before the ban came into effect (30.5%, 95% CI 19.7-43.9). A total of 41.1% (95% CI 38.9-43.4) of children had undetectable cotinine in 2008, up from 34.0 % (95% CI 30.8-37.3) in 2006. Geometric mean cotinine in all children combined was 0.21ng/ml (95% CI .20-.23) in 2008, slightly lower than in 2006, 0.24ng/ml (95% CI .21-.26). Conclusions: Predictions that the2007 legislative ban on smoking in enclosed public places would adversely affect children's exposure to tobacco smoke were not confirmed. While overall exposure in children has not been greatly affected by the ban, the trend towards the adoption of smoke-free homes by parents who themselves smoke has received fresh impetus.

BACKGROUND: The 2014 European Union (EU) Tobacco Products Directive (TPD) was negotiated in a changed policy context, following adoption of the EU's 'Smart Regulation' agenda, which transnational tobacco companies (TTCs) anticipated would increase their influence on health policy, and the WHO Framework Convention on Tobacco Control (FCTC), which sought to reduce it. This study aims to explore the scale and nature of the TTCs' lobby against the EU TPD and evaluate how these developments have affected their ability to exert influence. METHODS: Analysis of 581 documents obtained through freedom of information requests, 28 leaked Philip Morris International (PMI) documents, 17 TTC documents from the Legacy Library, web content via Google alerts and searches of the EU institutions' websites, plus four stakeholder interviews. RESULTS: The lobby was massive. PMI alone employed over 160 lobbyists. Strategies mainly used third parties. Efforts to 'Push' (amend) or 'Delay' the proposal and block 'extreme policy options' were partially successful, with plain packaging and point of sales display ban removed during the 3-year delay in the Commission. The Smart Regulation mechanism contributed to changes and delays, facilitating meetings between TTC representatives (including ex-Commission employees) and senior Commission staff. Contrary to Article 5.3, these meetings were not disclosed. CONCLUSIONS: During the legislative process, Article 5.3 was not consistently applied by non-health Directorates of the European Commission, while the tools of the Smart Regulation appear to have facilitated TTC access to, and influence on, the 2014 TPD. The use of third parties undermines Article 5.3.

OBJECTIVE: The tobacco industry spends large sums lobbying the European Union (EU) institutions, yet whether such lobbying significantly affects tobacco policy is not well understood. We used novel quantitative text mining techniques to evaluate the impact of industry pressure on the contested EU Tobacco Products Directive revision. DESIGN: Policy positions of 18 stakeholders including the tobacco industry, health NGOs and tobacco retailers were evaluated using their text submissions to EU consultations and impact assessments. Using Wordscores to calculate word frequencies, we developed a scale ranging from 0-tobacco industry to 1-public health organisations, which was then used to track changes in the policy position of the European Commission's 2010 consultation document, its 2012 final proposal and the European Parliament and Council's approved legislation in March 2014. RESULTS: Several stakeholders' positions were closer to the tobacco industry than that of health NGOs, including retailers (ω=0.35), trade unions (ω=0.34) and publishers (ω=0.33 and ω=0.40). Over time the European Commission's position shifted towards the tobacco industry from ω=0.52 (95% CI 0.50 to 0.54) to ω=0.40 (95% CI 0.39 to 0.42). This transition reflected an increasing use of words pertaining to business and the economy in the Commission's document. Our findings were robust to alternative methods of scoring policy positions in EU documents. CONCLUSIONS: Using quantitative text mining techniques, we observed that tobacco industry lobbying activity at the EU was associated with significant policy shifts in the EU Tobacco Products Directive legislation towards the tobacco industry's submissions. In the light of the Framework Convention on Tobacco Control, additional governance strategies are needed to prevent undue influence of the tobacco industry on EU policy making.

BACKGROUND: Standardised packaging (SP) of tobacco products is an innovative tobacco control measure opposed by transnational tobacco companies (TTCs) whose responses to the UK government's public consultation on SP argued that evidence was inadequate to support implementing the measure. The government's initial decision, announced 11 months after the consultation closed, was to wait for 'more evidence', but four months later a second 'independent review' was launched. In view of the centrality of evidence to debates over SP and TTCs' history of denying harms and manufacturing uncertainty about scientific evidence, we analysed their submissions to examine how they used evidence to oppose SP. METHODS AND FINDINGS: We purposively selected and analysed two TTC submissions using a verification-oriented cross-documentary method to ascertain how published studies were used and interpretive analysis with a constructivist grounded theory approach to examine the conceptual significance of TTC critiques. The companies' overall argument was that the SP evidence base was seriously flawed and did not warrant the introduction of SP. However, this argument was underpinned by three complementary techniques that misrepresented the evidence base. First, published studies were repeatedly misquoted, distorting the main messages. Second, 'mimicked scientific critique' was used to undermine evidence; this form of critique insisted on methodological perfection, rejected methodological pluralism, adopted a litigation (not scientific) model, and was not rigorous. Third, TTCs engaged in 'evidential landscaping', promoting a parallel evidence base to deflect attention from SP and excluding company-held evidence relevant to SP. The study's sample was limited to sub-sections of two out of four submissions, but leaked industry documents suggest at least one other company used a similar approach. CONCLUSIONS: The TTCs' claim that SP will not lead to public health benefits is largely without foundation. The tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for highly resourced corporations to slow, weaken, or prevent public health policies.

Since scholarly interest in corporate social responsibility (CSR) has primarily focused on the synergies between social and economic performance, our understanding of how (and the conditions under which) companies use CSR to produce policy outcomes that work against public welfare has remained comparatively underdeveloped. In particular, little is known about how corporate decision-makers privately reconcile the conflicts between public and private interests, even though this is likely to be relevant to understanding the limitations of CSR as a means of aligning business activity with the broader public interest. This study addresses this issue using internal tobacco industry documents to explore British-American Tobacco's (BAT) thinking on CSR and its effects on the company's CSR Programme. The article presents a three-stage model of CSR development, based on Sykes and Matza's theory of techniques of neutralization, which links together: how BAT managers made sense of the company's declining political authority in the mid-1990s; how they subsequently justified the use of CSR as a tool of stakeholder management aimed at diffusing the political impact of public health advocates by breaking up political constituencies working towards evidence-based tobacco regulation; and how CSR works ideologically to shape stakeholders' perceptions of the relative merits of competing approaches to tobacco control. Our analysis has three implications for research and practice. First, it underlines the importance of approaching corporate managers' public comments on CSR critically and situating them in their economic, political and historical contexts. Second, it illustrates the importance of focusing on the political aims and effects of CSR. Third, by showing how CSR practices are used to stymie evidence-based government regulation, the article underlines the importance of highlighting and developing matrices to assess the negative social impacts of CSR.

Objectives: To examine how transnational tobacco companies (TTCs) tried to penetrate the Bulgarian cigarette market and influence tobacco excise tax policy after the fall of communism and during Bulgaria's accession to the European Union (EU). Design: Analysis of internal tobacco industry documents supplemented by analysis of press coverage, tobacco industry journals, market reports and key informant interviews. Results: TTCs have been involved in cigarette smuggling to and through Bulgaria since at least 1975 and used smuggling as a market-entry strategy. National tobacco company Bulgartabac appears to have been involved in smuggling its own cigarettes from and reimporting them to Bulgaria. Since Bulgaria's accession to the EU opened the market to the TTCs, TTCs have exaggerated the scale of the illicit trade to successfully convince politicians and public health experts that tax increases lead to cigarette smuggling. Yet, sources point to TTCs' continued complicity in cigarette smuggling to and through Bulgaria between 2000 and 2010. TTCs aimed to influence the Bulgarian tobacco excise tax regime, import duties and pricing mechanism, but appear to have been less successful than in other former communist countries in part due to the co-existence of a state-owned tobacco company. Undisclosed meetings between the tobacco industry and government ministers and officials are ongoing despite Bulgaria being a party to the Framework Convention on Tobacco Control (FCTC). Conclusions: The TTCs continued involvement in smuggling suggests that deals in 2004, 2007 and 2010 which the European Commission has reached with TTCs to address cigarette smuggling are inadequate. The TTCs' continued access to policymakers suggests that the FCTC is not being properly implemented.

INTRODUCTION: Historical evidence, predominantly from high-income countries (HICs), shows that the tobacco industry uses a recurring set of arguments and techniques when opposing tobacco control policies. This data formed the basis of a model of tobacco industry political activity known as the policy dystopia model (PDM). The PDM has been widely used in tobacco control research and advocacy and has subsequently been shown relevant to other unhealthy commodities industries in both HICs and low-income and middle-income countries (LMICs). Before it can be validated as a generic tool for researching corporate influence on policy, one needs to determine whether the PDM successfully captures contemporary corporate political activities in LMICs. METHOD: We conducted semistructured interviews with 22 LMIC-based advocates and used the transcripts as the primary data source. The discursive and instrumental taxonomies constituting the PDM served as the starting point for the coding framework. Using thematic analysis, we combined deductive and inductive coding to ensure we captured all strategies from the PDM and the interviews. RESULTS: This study found that the tobacco industry uses a set of discursive and instrumental strategies that is largely consistent across LMICs and with the PDM. We identified several minor contextual nuances absent from the PDM. Some of these nuances were characteristic to individual countries, while others to LMICs more broadly. They included the argument that tobacco control policies unfairly punish reputable tobacco industry actors, and an emphasis on instrumental strategies centred around maintaining a good image, rather than rehabilitating a tarnished image as emphasised in the PDM. CONCLUSIONS: Allowing for the nuances identified in this study, the PDM has been found to be fit for purpose. The revised model should now be tested through in-depth LMIC case studies and could be used to facilitate comparative studies of unhealthy commodity industries' political activities.

Over the past fifteen years, an inter-connected set of regulatory reforms, known as Better Regulation, has been adopted across Europe, marking a significant shift in the way European Union (EU) policies are developed. There has been little exploration of the origins of these reforms, which include mandatory ex-ante impact assessment. Drawing on documentary and interview data, this paper discusses how and why large corporations, notably British American Tobacco (BAT), worked to influence and promote these reforms. Our analysis highlights: (i) how policy entrepreneurs with sufficient resources (such as large corporations) can shape the membership and direction of advocacy coalitions; (ii) the extent to which 'think tanks' may be prepared to lobby on behalf of commercial clients; and (iii) why regulated industries (including tobacco) may favour the use of 'evidence-tools', such as impact assessments, in policymaking. We argue a key aspect of BAT's ability to shape regulatory reform involved the deliberate construction of a vaguely defined idea that could be strategically adapted to appeal to diverse constituencies. We discuss the theoretical implications of this finding for the 'Advocacy Coalition Framework', as well as the practical implications of the findings for efforts to promote 'transparency' and public health in the EU.

European policymakers have recently become increasingly committed to using Impact Assessment (IA) to inform policy decisions. Welcoming this development, the public health community has not yet paid sufficient attention to conceptual concerns about IA or to corporate efforts to shape the way in which IA is used. This essay is a thematic analysis of literature concerning IA and associated tools and a related assessment of the European Union's (EU) new 'integrated' IA tool. Eight key concerns regarding IA are identified from the literature, many of which relate to the potential for undue corporate influence. Assessment of the EU's IA tool suggests that many of these concerns are valid. The findings raise crucial questions about the role of IA in public policy. By focusing mainly on the impact on the economy and business environment, the EU's current approach to IA may undermine healthy public policy. Those interested in public health need to acknowledge and respond to the problems associated with IA and evaluate the effects of 'integrated' IA tools on policy decisions affecting public health.